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Medtronic (MDT) Wins CE Mark for 3T MR-Safe CRT-Ds (revised)

Medtronic plc 's MDT cardiac resynchronization therapy defibrillators (CRT-Ds) recently won the CE Mark approval for undergoing 3 Tesla (T) magnetic resonance imaging (MRI) scans. Notably, Medtronic's CRT-Ds will now be the first and only such device to commercially allow patients to receive the 3T MRI, which offers the highest available magnetic strength in imaging diagnostic procedures.

Interestingly, patients implanted with Medtronic's Claria MRI Quad CRT-D SureScan, Amplia MRIQuad CRT-D SureScan or Compia MRI Quad CRT-D SureScan systems, are already allowed to undergo 1.5T MRI scan without any restrictions. All these three CRT-Ds are currently available in Europe to treat heart failure patients and reduce the risk of a sudden cardiac arrest in them. Among these, only the Claria CRT-D is not approved for sale in the U.S.

With physicians nowadays increasingly advising patients to undergo MRI scans to diagnose critical conditions such as stroke, cancer, Alzheimer's disease, and muscle, bone and joint pain; we believe the aforementioned CE Mark approval will encourage more patients to opt for Medtronic's MRI-safe CRT-Ds. This, in turn, will fetch higher profits for the company from its international business.

In patients with irregular heart beats, an implanted CRT-D sends small, undetectable electrical impulses to help the heart beat in a more synchronized pattern. Per management estimates, almost 40% of CRT patients require to undergo an MRI within 4 years after receiving a device.

So far, due to the unavailability of such MR-safe CRT-Ds, thousands of heart failure patients were deprived of MRI scans in many instances. This is because patients with earlier versions of CRT-Ds were found to face life risk if they underwent an MRI-scan. The latest approval declares Medtronic's CRT-Ds compatible with the highest degree of MRI-scans, thus taking care of much of the risk issues faced in this regard.

Notably, the three aforementioned CRT-Ds of Medtronic are available in variant shapes, can reduce lead programming to two minutes, and facilitate reduced phrenic nerve stimulation (PNS) occurrence as well as optimal pacing configurations in each patient.

In addition to the full line of CRT-Ds, Medtronic's MR-safe cardiac rhythm and heart failure devices and leads, that were previously approved for 1.5 Tesla, are now approved for full body scans in both 1.5 and 3T MRI machines in Europe.

In this context we note that the company has received the FDA nod for both Amplia MRI Quad CRT-D SureScan and Compia MRI Quad CRT-D SureScan systems, on Feb 5, 2016.

The global market for congestive heart failure treatment devices is expected to reach $5.9 billion by the year 2016 at a CAGR of 11.7% while the European market potential is expected to touch $1.5 billion at a CAGR of 7.5% for the same period.

Given the aforementioned developments, we expect the recent received CE Mark approval to allow Medtronic to capture larger shares in this market, going ahead.

Zacks Rank

Currently, Medtronic has a Zacks Rank #3 (Hold). Some better-ranked medical product stocks are Hill-Rom Holdings, Inc. HRC , OraSure Technologies, Inc. OSUR and Vascular Solutions Inc. VASC . All the three stocks sport a Zacks Rank #1 (Strong Buy).

(We have revised this article to correct a mistake. The previous version, published on Feb 24, should not be relied upon.)

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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